Food and Drug Administration

News about Food and Drug Administration, including commentary and archival articles published in The New York Times.

Chronology of Coverage

Jul. 29, 2015

Food and Drug Admin approves medical balloon that helps obese patients lose weight by filling up stomach; system is manufactured by Reshape Medical. MORE

Jul. 17, 2015

Op-Ed article by cardiologists Rita F Redberg and Sanket S Dhruva warns that 21st Century Cures Act passed by House of Representatives will weaken Food and Drug Administration's already ineffective oversight of medical devices; calls on Senate to reject provision of bill that will subject Americans to unsafe or untested medical devices. MORE

Jul. 14, 2015

Food and Drug Administration plans on asking makers of nonaspirin, nonsteroidal anti-inflammatory painkillers to change labels to reflect new evidence that drugs increase risk of heart attacks and strokes. MORE

Jul. 11, 2015

Health care legislation written by Reps Fred Upton, Republican of Michigan, and Diana DeGette, Democrat of Colorado, passes easily; bill, which would update FDA approval process and increase funding to National Institutes of Health, would be funded by sale of oil from strategic petroleum reserve. MORE

Jul. 10, 2015

Food and Drug Administration will strengthen warnings about risk of heart attack and stroke on labels for over-the-counter non-aspirin pain killers. MORE

Jul. 8, 2015

Food and Drug Admin approves Novartis's new heart failure drug Entresto, which has proved to cut deaths and hospitalization from condition by 20 percent. MORE

Jun. 24, 2015

Mark Bittman Op-Ed column welcomes news that Food and Drug Administration has banned foods containing trans fats, but argues that it should not allow companies grace period of three years to remove the deadly substance; says Americans have been hoodwinked over past 100 years into thinking that margarine, Crisco and other forms of hydrogenated oils were healthier substitutes for butter; notes decision is all the easier given that butter and other natural fats taste better. MORE

Jun. 19, 2015

Editorial applauds Food and Drug Administration's order that food industry remove artificial trans fats from food supply within three years; holds removal of trans fats may be simplest and quickest way to save tens of thousands of lives. MORE

Jun. 17, 2015

Two generic versions of ADHD medication Concerta remain on market despite evidence that they are inferior; Food and Drug Administration reported that generics were less effective than Concerta and gave Mallinckrodt Pharmaceuticals and UCB six months to prove otherwise, deadline that has since lapsed with neither company announcing plans to withdraw the drugs. MORE

Jun. 14, 2015

Panel's surprise recommendation to FDA to approve Sprout Pharmaceutical drug flibanserin, first pill to bolster women's libido, raises questions about coalition of prominent feminists who campaigned for drug's approval; campaign divided women's health community, with critics saying it politicized scientific process and potentially played down health risks; those paid to promote drug include Susan Scanlan, whose Even the Score group argued that women's sexuality has been marginalized by medical establishment. MORE

Jun. 12, 2015

Editorial warns recommendation by federal advisory panel that FDA approve Sprout Pharmaceutical drug flibanserin, which treats female sexual dysfunction, raises concerns about safety of drug; notes drug has been shown to be only marginally effective; calls for approval only if safety concerns are addressed. MORE

Jun. 11, 2015

Advisory panel recommends that Food and Drug Admin approve evolocumab, second in new class of drugs that can drastically lower cholesterol levels; doctors hope drugs may help those at high risk of heart attack who are unable to control their conditions with statins. MORE

Jun. 11, 2015

Op-Ed article by policy experts Gregg Gonsalves, Mark Harrington and David A Kessler staunchly opposes passage of the 21st Century Cures Act; warns act could lower standards for approval of medical products and place patients at potential risk; traces history of current FDA approval standards to AIDS crisis in the 1980s, saying new policies will disrupt a system that is agile and effective. MORE

Jun. 10, 2015

Expert panel recommends Food and Drug Admin approve strong new drug to protect against heart attacks; it would be first in new group of medicines that substantially lower levels of cholesterol, leading cause of heart disease; drugs are made by Sanofi, Regeneron Pharmaceuticals and Amgen. MORE

Jun. 5, 2015

Food and Drug Administration advisory committee votes to approve flibanserin, making it first drug to treat diminished sexual desire in women; action is lauded by some women's organizations as move toward sexual equality by giving women counterpart to Viagra; critics point out side effects and complain of undue industry influence. MORE

Jun. 1, 2015

Even the Score, campaign backed by Sprout Pharmaceuticals and some women's groups, seeks to show that FDA is displaying gender bias by not approving drug flibanserin, which restores libido in women; Sprout is maker of the drug, and campaign has highlighted how FDA has approved numerous drugs to help men have sex, but none for women. MORE

May. 26, 2015

Joe Nocera Op-Ed column describes speaking with Mitch Zeller, head of Food and Drug Administration's Center for Tobacco Products, about debate surrounding electronic cigarettes; notes Zeller believes challenge he is faced with is considering relative dangers of different nicotine delivery devices, and that society should recognize that ultimately, debate is about minimizing risks to those addicted to nicotine. MORE

May. 22, 2015

House will take up vote on bill that sets aside $10 billion over five years for National Institutes of Health and some half a billion dollars for the FDA in effort to hasten approval of drugs and medical devices. MORE

May. 21, 2015

Op-Ed article by Profs I Glenn Cohen and Eli Y Adashi opposes new draft recommendations from Food and Drug Admin that allows gay men to donate blood following one year of celibacy; argues while rule is improvement from previous lifetime ban, it still abandons scientific reason in favor of fear and stigma that were established early in AIDS crisis. MORE

May. 20, 2015

Food and Drug Admin issues rule requiring drug makers who service livestock to report detailed information about antibiotics sales by animal types, part of effort to address antibiotic resistance problem. MORE

May. 13, 2015

Food and Drug Administration advisory committee recommends approval for Orkambi, drug developed by Vertex Pharmaceuticals that could help nearly half of all patients with cystic fibrosis. MORE

May. 8, 2015

Food and Drug Administration releases documents showing that Blue Bell Creameries was aware of listeria in its factories as early as 2013, years before recent recall of all its products; company acknowledges failure to respond and inadequate cleaning methods. MORE

May. 8, 2015

Amarin Pharma brings novel free-speech suit against Food and Drug Administration, saying agency has no constitutional grounds to bar pharmaceutical companies from discussing off-label medication usage with doctors; argues FDA has no right to bar transmission of accurate information, but critics say promotion of off-label use dangerously sidesteps agency's authority. MORE

May. 4, 2015

Thousands of women who contend they were seriously hurt by contraceptive implant Essure are asking Food and Drug Admin to remove device from market and warn public about its complications; disturbing long-term data on women using device is published in Journal of Minimally Invasive Gynecology after eight-year delay. MORE

May. 1, 2015

Food and Drug Administration approves injection called Kybella for reduction of fat deposits under the chin. MORE

May. 1, 2015

House releases scaled-back draft of bill intended to speed up pace at which Food and Drug Administration approves drugs; critics had charged that changes would impact public safety. MORE

Apr. 29, 2015

Pharmaceuticals are racing to develop first drugs for celiac disease, condition that is now understood to be far more common than previously thought; drugs, which will not reach market until at least 2018, would not eliminate need for gluten-free diet, but could alleviate symptoms from trace elements; Food and Drug Admin is moving to develop standards for measuring drugs' effectiveness. MORE

Apr. 23, 2015

Op-Ed article by policy experts David A Kessler and Matthew L Myers warns e-cigarette use is skyrocketing among young people, as tobacco companies deploy same marketing tactics they used to addict generations of teenagers to cigarettes; calls on FDA to undertake robust regulation of e-cigarette marketing techniques. MORE

Apr. 17, 2015

Food and Drug Admin approves first generic substitute for multiple sclerosis drug Copaxone, the biggest-selling product for Teva Pharmaceutical Industries; generic, developed by Sandoz and Momenta Pharmaceuticals, could introduce competition for drug that costs some $60,000 per year. MORE

Apr. 16, 2015

Food and Drug Administration approves Corlanor, drug used to treat chronic heart failure that has shown mixed results in clinical trials. MORE

Apr. 13, 2015

Editorial criticizes Food and Drug Administration for its lethargic regulation of dietary supplements containing dangerous stimulant BMPEA; contends agency has been compromised by too many officials with strong ties to industry in key positions; calls on Congress to enact conflict-of-interest laws that would limit officials from acting in cases related to former employment. MORE

Apr. 12, 2015

Researchers at UCLA who developed drug aimed at diagnosing chronic traumatic encephalopathy, degenerative brain disease linked to repeated head trauma, have come under fire by Food and Drug Administration for improperly marketing drug and making overstated claims about its efficacy. MORE

Apr. 11, 2015

Panel of experts assembled by Food and Drug Admin rejects argument from company Swedish Match that its smokeless tobacco product Snus is far less harmful than cigarettes and should be labeled as a less dangerous; panel's recommendations are not binding but anti-smoking advocates speculate that, based on such findings, FDA would be unlikely to approve company's application. MORE

Apr. 9, 2015

Swedish tobacco company Swedish Match hopes to convince Food and Drug Administration that snus, smokeless tobacco product popular in Sweden, is less harmful than cigarettes and should not be labeled with same harsh health warnings; if successful, decision could fundamentally change tobacco regulation in United States. MORE

Apr. 9, 2015

Editorial criticizes Congressional failure to appropriate funds for Food Safety Modernization Act; warns without reform, consumers will continue to be exposed to dangerous food-borne illness that results in roughly 128,000 hospitalizations and 3,000 deaths annually; calls on lawmakers to find necessary resources, whether through user fees or appropriations. MORE

Apr. 8, 2015

Congress has appropriated less than half of $580 million requested by Congressional Budget Office to carry out changes required by Food Safety Modernization Act passed in 2010; law gives FDA new powers to prevent food poisoning outbreaks; at issue is resistance by food industry to paying user fees that help fund law. MORE

Apr. 7, 2015

A new study makes public what the F.D.A. did not: the names of diet and workout supplements that contain the chemical BMPEA, which is similar to amphetamines. MORE

Mar. 28, 2015

Generic drug makers challenge Food and Drug Admin's plan that would require them to take initiative to update their labels whenever health risks are discovered, shift that would expose them to legal liability. MORE

Mar. 21, 2015

Food and Drug Administration says bruise-resistant potatoes and nonbrowning apples that are genetically engineered by J R Simplot Company and Okanagan Specialty Fruits, respectively, are as safe and nutritious as their normal counterparts; FDA rarely issues news releases about reviews of genetically modified crops, but did so in apparent acknowledgment of public attention paid to these two particular crops. MORE

Mar. 13, 2015

Food and Drug Admin, responding to deadly bacterial infections from medical scopes, moves to increase regulation on manufacturers of reusable medical devices; changes will not effect devices already on the market. MORE

Mar. 7, 2015

Food and Drug Admin approves drug Zarxio, produced by Sandoz, first so-called biosimilar drug approved for use in United States; drug helps prevent infections in cancer patients undergoing chemotherapy treatment, and its approval will open door to new class of potentially cheaper biologic drugs, which are made using living cells and not synthesized from chemicals like typical drugs. MORE

Mar. 4, 2015

Food and Drug Admin will require manufacturers of testosterone drugs to change labels to warn that drugs may increase risk of heart attack or stroke and to specify that drugs should not be used to treat conditions associated with aging; use of testosterone drugs has increased fourfold since early 2000s for men in their 40s. MORE

Feb. 26, 2015

Dr Stephen Ostroff of Food and Drug Administration says agency did not review manufacturers' data on procedures necessary to clean duodenoscopes that recently infected seven patients with drug-resistant bacteria at Ronald Reagan UCLA Medical Center; reports that FDA has now asked device makers to show evidence that their recommended disinfection methods work. MORE

Feb. 25, 2015

Some critics say drug maker Shire is going too far in its marketing of Vyvanse, amphetamine-based drug that was recently approved to treat binge-eating disorder; Shire spent years before approval shaping public perception and diagnosis of binge-eating disorder, much as it did with ADHD in the past; controversy highlights marketing strategy that has yielded billions in profits and that many say presents public danger. MORE

Feb. 20, 2015

Food and Drug Admin issues alert concerning difficult-to-clean medical scopes that may be infecting patients with drug-resistant bacteria after they are inserted down throats; follows report of two patient deaths in California; alert highlights growing medical concern about superbug known as CRE, which is resistant to even last-resort antibiotics and could prove a public health hazard were it to spread from hospitals. MORE

Feb. 20, 2015

Food and Drug Administration approves 23andMe test for prospective parents to see if they carry mutations that could cause rare disease called Bloom syndrome in their children. MORE

Feb. 12, 2015

Editorial hails Food and Drug Administration's proposed simplified process for doctors to get experimental drugs for critically ill patients; holds their patients suffering life-threatening illnesses can only benefit from plan. MORE

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The Food and Drug Administration said it would ask drug manufacturers to change the labels to reflect evidence that nonaspirin, nonsteroidal anti-inflammatory drugs increased the risk of heart attacks and strokes.

Nathan Myhrvold, the Mad Hatter of modernist cooking, invited the movement’s leading chef, Ferran Adrià, over for a 50-course, lab-prepared meal. It was a lot to digest, sure, but what does a feast like this mean for the future of eating?